Draeger Medical Systems, Inc

FDA inspection history in Andover, Massachusetts, 2019

1
Form 483

Every document, by year

  • Form 483

2019: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2019One Form 483, at Andover, Massachusetts.

Cited most

Across all Draeger Medical Systems observations on file

  • 21 CFR 807.81
    When a premarket notification submission is required
    1

The complete Draeger Medical Systems file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Sites

Documents

1 on file, newest first
DateDocumentPrice
2019-09-20483 Form 483$99

Investigators on these documents

Justine M. Corson (1)Matthew B. Hazelett (1)

FEI number 3005783425 · most recent document Sep 20, 2019

About Draeger Medical Systems, Inc

How many FDA Form 483s has Draeger Medical Systems, Inc received?

FDA Intel has 1 Form 483 on file for Draeger Medical Systems, Inc; the most recent is dated Sep 20, 2019.

When was Draeger Medical Systems, Inc last inspected by FDA?

The most recent FDA inspection document on file for Draeger Medical Systems, Inc is a Form 483 dated Sep 20, 2019, for the site in Andover, Massachusetts.

What did FDA cite at Draeger Medical Systems, Inc?

The regulations cited most in the observations on file for Draeger Medical Systems, Inc are 21 CFR 807.81 (When a premarket notification submission is required), 1 time.